6640--GoPCR Cobas Liat Starter Kit Program

Asheville Western NC VA Health Care System Pathology and Laboratory Medicine Service Waived PCR SARS-COVID-19, Influenza A/B, and Strep A Test System Statement of Work Asheville Western NC Healthcare Care System is seeking to purchase 5 CLIA waived Real-Time PCR Point-of-Care Roche LIAT instruments. PRICES AND TERMS: This is a one-time purchase for equipment to be delivered to the following location: Charles George VA Medical Center Basement Floor Laboratory 1100 Tunnel Road Asheville, NC 28805 Attention: Stephanie Quittner TERM OF AGREEMENT: This will be a one-time purchase for a firm-fixed price. DELIVERY TERMS: Delivery shall be within 30 days of award SCOPE OF PROCUREMENT: Purchase of FIVE (5) Roche Cobas Liat PCR analyzers Each system shall be a complete system for testing and reporting the SARS-CoV-19 & Influenza A/B using Real-Time PCR molecular testing methodology with FDA EUA approval for waived testing locations. Each system shall be a complete system for testing and reporting Strep A using Real-Time PCR molecular testing methodology with FDA approval for waived testing locations. The proposed systems shall have a COVID, Flu or Strep time to result, including hands-on preparation, of less than (<) 30 minutes. GENERAL REQUIREMENTS: The Contractor shall pay all shipping costs for the analyzer(s). The Contractor shall perform, to the satisfaction of the Government, all installation requirements for testing the novel SARS CoV-19, which may include the following: precision, method comparison with current analyzer, accuracy (recovery), sensitivity and specificity at no cost to the Government. The Contractor shall report data in an organized, clearly comprehensible format. The Contractor agrees to provide an on-site technical support specialist for the duration of the equipment installation, set-up, and until the performance of the validation studies are complete. The Contractor shall provide on-site or virtual education and training. Training shall include basic operation, quality control, interpretation of results, reporting of results, required user performed maintenance, and troubleshooting. The Medical Center is to be invoiced in accordance with selected project management dates. Terms are net 30 days. The use of a purchase order system is preferable. 3.2 CONTRACTOR SUPPORT During the first year of operations (not instrument shipment), the vendor will provide technical support services at no additional charge. Technical support by telephone shall be available 5 days a week, 8 hours a day. Technical support shall return all downtime calls within one hour. Should on-site service be required, the contractor s field service organization shall provide on-site service response within 24 hours after being contacted. All replacement instrument/equipment must be received within 24 hours from the time the on-site service arrives. The repair person shall also, prior to departure, provide the visited site with written documentation of services performed. Technical support shall place a service call for repairs if the technologist is unable to repair the analyzer within one hour of trouble-shooting with the hotline or on weekends/holidays/irregular tours when technologists may be unable to work with the hotline due to the facility s staffing. Requests for services will be through the contractor. The vendor s technical service representatives must comply with the facility s requirements for onsite vendor representatives (for the CGVAMC, it is the RepTrac system). This may require a low risk background investigation by federal authorities paid for by the vendor. After the first year, the vendor will allow the medical center to purchase annual service contracts providing the same service as listed above. The annual cost for these annual service contracts (years 2 thru year 5) will be provided in the quote submitted by the vendor. CHANGES TO THE STATEMENT OF WORK The contracting officer is the only person authorized to approve changes or modify any of the requirements under this contract. The Contractor shall communicate with the Contracting Officer on all matters pertaining to contract administration. Only the Contracting Officer is authorized to make commitments or issue changes which will affect price, quantity, or quality of performance of this contract. In the event the contractor effects any such change at the direction of any person other than the contracting officer, the change shall be considered to have been made without authority and no adjustment will be made in the contract price to cover any increase in costs incurred as a result thereof. 3.4. GOVERNMENT RESPONSIBILITIES The vendor will agree to the terms and conditions contained in this statement of work regarding the purchase of equipment and service. Any change in any of the terms and conditions of this agreement must be in writing. INFORMATION SECURITY Information made available to the contractor by VA for the performance or administration of this contract or information developed by the contractor/subcontractor in performance or administration of the contract shall be used only for those purposes and shall not be used in any other way without the prior written agreement of the VA. This clause expressly limits the contractor/subcontractor's rights to use data as described in Rights in Data - General, FAR 52.227-14(d) (1). VA information should not be co-mingled, if possible, with any other data on the contractors/subcontractor s information systems or media storage systems in order to ensure VA requirements related to data protection and media sanitization can be met. If co-mingling must be allowed to meet the requirements of the business need, the contractor must ensure that VA s information is returned to the VA or destroyed in accordance with VA s sanitization requirements. VA reserves the right to conduct on site inspections of contractor and subcontractor IT resources to ensure data security controls, separation of data and job duties, and destruction/media sanitization procedures are in compliance with VA directive requirements. Prior to termination or completion of this contract, contractor/subcontractor must not destroy information received from VA, or gathered/created by the contractor in the course of performing this contract without prior written approval by the VA. Any data destruction done on behalf of VA by a contractor/subcontractor must be done in accordance with National Archives and Records Administration (NARA) requirements as outlined in VA Directive 6300, Records and Information Management and its Handbook 6300.1 Records Management Procedures, applicable VA Records Control Schedules, and VA Handbook 6500.1, Electronic Media Sanitization. Self-certification by the contractor that the data destruction requirements above have been met must be sent to the VA Contracting Officer within 30 days of termination of the contract. The contractor/subcontractor must receive, gather, store, back up, maintain, use, disclose and dispose of VA information only in compliance with the terms of the contract and applicable Federal and VA information confidentiality and security laws, regulations and policies. If Federal or VA information confidentiality and security laws, regulations and policies become applicable to the VA information or information systems after execution of the contract, or if NIST issues or updates applicable FIPS or Special Publications (SP) after execution of this contract, the parties agree to negotiate in good faith to implement the information confidentiality and security laws, regulations and policies in this contract. e. The contractor/subcontractor shall not make copies of VA information except as authorized and necessary to perform the terms of the agreement or to preserve electronic information stored on contractor/subcontractor electronic storage media for restoration in case any electronic equipment or data used by the contractor/subcontractor needs to be restored to an operating state. If copies are made for restoration purposes, after the restoration is complete, the copies must be appropriately destroyed.